RecruitingPhase 2NCT06291064

Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

Sponsor

University of Chicago

Enrollment

85 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Summary

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC). All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different chemotherapy regimens for Nigerian women with triple-negative breast cancer (TNBC) — a type of breast cancer that does not respond to hormone or HER2-targeted therapies. The goal is to find the most effective and tolerable treatment before surgery (neoadjuvant chemotherapy). **You may be eligible if...** - You are a woman aged 18 to 70 in Nigeria - You have a breast tumor of at least 2 cm that can be biopsied - Your cancer is confirmed as triple-negative breast cancer by lab testing - Your cancer is stage IIA to IIIC - You have not previously received chemotherapy for this cancer - You are not pregnant or breastfeeding and are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have already received chemotherapy for this cancer - You are pregnant or nursing - You have significant blood count or organ function problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.

DRUGEpirubicin

Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.

DRUGDocetaxel

Docetaxel is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Carboplatin. Dosing will start after treatment with Epirubicin and Cyclophosphamide (EC) is completed.

DRUGCarboplatin

Carboplatin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Docetaxel. Dosing will start after treatment with EC is completed.

PROCEDUREBreast Surgery

Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.

DRUGCapecitabine

Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.

Locations(4)

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria

Lagos University Teaching Hospital

Yaba, Lagos, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, Nigeria

University of Ibadan Hospital

Ibadan, Oyo State, Nigeria

View Full Details on ClinicalTrials.gov

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NCT06291064